Zobrazeno 1 - 10
of 25
pro vyhledávání: '"Parag Kolhe"'
Autor:
Annie, Leahy, Jennifer, Juneau, Kathleen, Souza, Corinne, Miller, Nhung, Nguyen, Herb, Lutz, Parag, Kolhe
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 77:18-26
Regulatory and manufacturing requirements exist to perform product-specific microbial retention testing on sterilizing filters. The implementation of a Quality by Design approach to sterilizing filtration supports a paradigm that would obviate the ne
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d0ce112c033a32d551e93a6eb4fdfc5b
https://doi.org/10.5731/pdajpst.2022.012739
https://doi.org/10.5731/pdajpst.2022.012739
Autor:
Vaida Linkuvienė, Emma L. Ross, Lindsey Crawford, Sarah E. Weiser, Damen Man, Stephen Kay, Parag Kolhe, John F. Carpenter
Publikováno v:
Journal of Pharmaceutical Sciences. 111:1024-1039
In hospitals, often drug products in intravenous (IV) bags are transported via pneumatic tube systems (PTS). The goal of this study was to evaluate the effects of such transportation of protein products on particle formation in polyvinyl chloride (PV
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d85848140d4d5096da7d08f1ad03e833
https://doi.org/10.1016/j.xphs.2022.01.016
https://doi.org/10.1016/j.xphs.2022.01.016
Autor:
Shawn Cao, Vakhtang Loladze, Dennis T. Yang, Tapan K. Das, Klaus Wuchner, Linda O. Narhi, George M. Bou-Assaf, Anacelia Rios, Friederike Junge, Ankit R. Patel, Valentyn Antochshuk, Stanley C. Kwok, Nataliya Afonina, Miguel Saggu, Mario Hubert, Parag Kolhe, Luis Montrond
Publikováno v:
Journal of Pharmaceutical Sciences. 109:830-844
One of the major product quality challenges for injectable biologics is controlling the amount of protein aggregates and particles present in the final drug product. This article focuses on particles in the submicron range (2 μm). A cross-industry c
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a4ddcc7a803679c340231f989383fce7
https://doi.org/10.1016/j.xphs.2019.10.025
https://doi.org/10.1016/j.xphs.2019.10.025
Autor:
Parag Kolhe, Deep S. Bhattacharya
Publikováno v:
Practical Aspects of Vaccine Development ISBN: 9780128143575
The control strategy is a critical aspect of vaccine drug development. This chapter introduces concepts of control strategy and how the holistic control strategy can be applied for a multicomponent suspension vaccine drug product. Various concepts an
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::2dc76bdd43dfaaeb82bc4d988c6496c2
https://doi.org/10.1016/b978-0-12-814357-5.00010-6
https://doi.org/10.1016/b978-0-12-814357-5.00010-6
Autor:
Jianxin Guo, Parag Kolhe
Publikováno v:
Practical Aspects of Vaccine Development ISBN: 9780128143575
Practical Aspects of Vaccine Development
Practical Aspects of Vaccine Development
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::8f6494da874bd0ac40bb0b7bd7bc799f
https://doi.org/10.1016/b978-0-12-814357-5.00009-x
https://doi.org/10.1016/b978-0-12-814357-5.00009-x
Autor:
Mansoor M. Amiji, Salvador F. Ausar, Deep Bhattacharya, Michael Bruchsaler, Valeria Caputo, Roberta Antonia Diotti, Kanwal Gill, Sonia Gregory, Jianxin Guo, Manish Gupta, Akshay Jain, Parag Kolhe, Vamsi Krishna, Alex Langford, Nicholas R. Larson, Aaron Latal, Rushit N. Lodaya, Malte Meppen, C. Russell Middaugh, Leanne Minall, Paul Nelson, Derek T. O'Hagan, Katherine E. Odneal, Adora M. Padilla, Nicole M. Payton, Aslin Rodriguez Nassif, Giuseppe Andrea Sautto, Lee C. Smith, Daniela Stranges, Yangjie Wei, Chris Wiley
Publikováno v:
Practical Aspects of Vaccine Development ISBN: 9780128143575
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::a9774071f5ea9416d524ecd15701c745
https://doi.org/10.1016/b978-0-12-814357-5.01002-3
https://doi.org/10.1016/b978-0-12-814357-5.01002-3
Publikováno v:
Journal of Pharmaceutical Sciences. 108:2406-2414
Particulate matter present in drug products intended for parenteral administration to patients is typically monitored and controlled in the finished drug product to minimize potential risks to patients. In contrast to particulates found in drug produ
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b2144796a0309f1389d21ec7f64aabcc
https://doi.org/10.1016/j.xphs.2019.02.020
https://doi.org/10.1016/j.xphs.2019.02.020
Autor:
Parag Kolhe, Satoshi Ohtake
Practical Aspects of Vaccine Development provides an academic and industry perspective on vaccine development and manufacturing. With the increasing complexity of vaccine products in development, there is a need for a comprehensive review of the curr
Publikováno v:
Journal of Pharmaceutical Sciences. 105:2009-2013
A case study is presented for a vaccine drug product (DP) that showed variable re-dispersion times between syringes within a given DP lot and between different DP lots when shipped from the manufacturing site to the receiving site. A simulated shippi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::750f1094b6710a46fb099088c18cc553
https://doi.org/10.1016/j.xphs.2016.03.023
https://doi.org/10.1016/j.xphs.2016.03.023
Autor:
Parag Kolhe, Sumit Goswami
Publikováno v:
Challenges in Protein Product Development ISBN: 9783319906010
Protein drug substance is typically frozen to enable manufacturing flexibility through prolonging the shelf life of drug substance and providing better biochemical stability. The process of freezing and thawing of bulk protein solutions poses several
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::244f5e8ac1e229976265a38f0fdfe037
https://doi.org/10.1007/978-3-319-90603-4_15
https://doi.org/10.1007/978-3-319-90603-4_15